FDA-approved medical devices and algorithms: an online database | Digital Medicine

Credits:  Stan Benjamens, Pranavsingh Dhunnoo & Bertalan Meskó

Introduction

The 2010s has brought a rise in the number of studies and papers discussing the role of artificial intelligence (AI) and machine learning (ML) in medicine and healthcare (AI/ML). The number of life science papers describing AI/ML rose from 596 in 2010 to 12,422 in 2019. While we are at the beginning of the AI/ML era, the expectations are high and experts foresee that AI/ML shows potential for diagnosing, managing and treating a wide variety of medical conditions1.

Indeed, AI/ML-based technologies have been shown to support several medical specialties from radiology2 and oncology3 to ophthalmology4 and general medical decision-making5. ML models have been shown to reduce waiting times6; improve medication adherence7; customize insulin dosages8; or help interpret magnetic resonance images9, among others. AI/ML- based technologies are coming to electronic health record systems and AI based notifications and messaging systems.

We classify technology like AI/ML-based if official FDA announcements, communications by the company or other publicly available information resources used the expressions ‘deep learning,’ ‘machine learning,’ ‘deep neural networks,’ ‘artificial intelligence,’ and/or ‘AI’ to describe the technology11. For simplicity, we use the term “AI/ML-based” to denote these technologies in this paper. With the increasing expertise and attention on AI/ML in the medical field, the opportunities and possible implications of its use are the topics of an ongoing debate12. A crucial element in this implementation debate is regulating such technologies.Because of the high-risk nature of these medical devices and the unknown consequences of using AI/ML for medical decision-making and data analysis, the FDA has stringent regulatory requirements for medical device licensing. Developers of AI/ML-based medical devices and algorithms have to go through rigorous processes that are time and resource consuming. This can be considered pivotal as a barrier for the introduction of AI/ML in medicine.

Before medical hardware or software is legally made available in the US market, the parent company has to submit it to the FDA for evaluation. For medically oriented AI/ML-based algorithms, the regulatory body has three levels of clearance, namely, 510(k)14, premarket approval15, and the de novo pathway16, each of which needs specific criteria to be fulfilled in order to be granted (Table 1). This process is similar to drug approvals.  

Table 1 Descriptions of the types of FDA approvals for AI/ML-based medical technologies.

From: The state of artificial intelligence-based FDA-approved medical devices and algorithms: an online database

Level of FDA clearance Description

510(k) clearance A 510(k) clearance for an algorithm is granted when it has been shown to be at least as safe and effective as another similar, legally marketed algorithm. The submitter seeking this clearance must provide substantial proof of equivalence in their application. Without approval of being substantially equivalent to the other algorithm, the one pending approval cannot be legally marketed.

Premarket approval Premarket approval is issued to algorithms for Class III medical devices. The latter are those that can have a large impact on human health and as such, their evaluation undergoes more thorough scientific and regulatory processes to determine their safety and effectiveness. In order to approve an application, the FDA determines that the device’s safety and effectiveness is supported by satisfactory scientific evidence. Upon approval, the applicant can proceed with marketing the product. de novo pathway Regarding the de novo classification, it is used to classify those novel medical devices for which there are no legally marketed counterparts, but which offer adequate safety and effectiveness with general controls. The FDA performs a risk-based assessment of the device in question before approval and allowing the device to be marketed.

Table 1 Descriptions of the types of FDA approvals for AI/ML-based medical technologies.

From: The state of artificial intelligence-based FDA-approved medical devices and algorithms: an online database

TABLE  Descriptions of the types of FDA approvals for AI/ML-based medical technologies. 

An infographic about the 29 FDA-approved, AI/ML-based medical technologies.

The two main medical specialties with AI/ML-based medical innovations are Radiology and Cardiology, with 21 (72.4%) and 4 (13.8%) FDA approved medical devices and algorithms respectively. The remaining medical devices and algorithms can be grouped as focusing on internal medicine/endocrinology, neurology, ophthalmology, emergency medicine, and oncology.

The medical field of radiology is the trendsetter regarding FDA-approved medical devices and algorithms, with the introduction of AI/ML-based solutions for worldwide applied image reading software. Examples are the three algorithms for Arterys Inc., Arterys Cardio DL, Arterys Oncology DL and Arterys MICA, which are connected to the workflow Picture Archiving and Communication Systems from main vendors as Siemens Healthineers AG (Germany) and GE Healthcare (USA)20. Six out of these 21 algorithms can be applied in the field of oncology, with three focusing on mammography analyses (ProFound™ AI Software V2.1, cmTriage and TransparaTM) and three others on CT-based lesion detection (Arterys Oncology DL, Arterys MICA and QuantX). This is followed by two algorithms focusing on brain image analyses, with innovations for stroke and hemorrhage detection (ContaCT, Accipiolx, and icobrain), and six algorithms to improve image processing, with noise and radiation dosage reduction (SubtlePET, Deep Learning Image Reconstruction, Advanced Intelligent Clear-IQ Engine, SubtleMR, AI-Rad Companion (Pulmonary) and AI-Rad Companion (Cardiovascular)). Another four algorithms focusing on acute care, with two algorithms for the assessment of pneumothorax (HealthPNX and Critical Care Suite), one focusing on wrist fracture diagnosis (OsteoDetect) and the Aidoc Medical BriefCase system for triage of head, spine, and chest injuries. The final two algorithms in this specialty can be applied for cardiovascular assessments, focusing on the assessment of the heart ejection fraction (EchoMD AEF Software and EchoGo Core).

During the past decade, the use of AI/ML-based medical innovations has become ubiquitous driven by specialty needs in the clinical process from diagnosis to remote monitoring and treatment.  Despite FDA approvals, end-users such as physicians, nurse practitioners must have the final word. Algorithms are continuously updated, and the FDA uses a "locked" or "adaptive" classification in order to monitor algorithms that 'learn' and change with time and use.

The authors clearly state the limitations for the FDA to accomplish this process, explaining that other organizations assess the accuracy of AI/ML-based devices.

eMurmer ID, CSD Labs GmbH), Apple Inc, being the ECG App and Apple Irregular Rhythm Notification Feature, Excel Medical Electronics, Spry Health, and Current Health, Stratoscientific, Inc. introduced the Steth IO device to analyze heart and lung sounds. BrainScope Company Inc. has introduced AI/ML for the evaluation of brain injuries. MindMotion GO (MindMaze SA), (Cantab Mobile, Cambridge Cognition Ltd), and seizure monitoring (Embrace, Empatica Srl.). 

QbCheck (QbTech AB) and ReSET-O (Pear Therapeutics Inc.). With QbCheck, healthcare workers can substantiate their diagnosis or rule out attention deficit hyperactivity disorder (ADHD), enhancing objective medical decisions in psychiatry29, whereas ReSET-O can be applied for patients with Opioid Use Disorder, providing cognitive behavioral therapy as a mobile medical application for prescription use only. As a next step, the ReSET-O algorithm will be used in a randomized controlled trial, which is scheduled to start this year (April 2020)30.

The FDA has a clinical trial protocol for drugs, which may also be applied to devices and AI/ML-based devices and software.

A challenge has developed for the FDAs search algorithm, which itself will require an AI/ML-based search-based method beyond its current version.

Users of AI/ML-based software need (CME) Continuing Medical Education in each specialty.

The ACMGE as the accrediting body for medical education should supervise this as a requirement for the training of physicians

Reference source:

The state of artificial intelligence-based FDA-approved medical devices and algorithms: an online database | npj Digital Medicine

Stressors Take Toll on Students’ Mental Health -

Xenia Shih Bion, MPH

Back to school time of year brings anxiety to some students while others are anxious to return to a routine discipline, friends, and sports.  The new routine of remote learning will cause new challenges for some, while some students will thrive in an independent environment.  In some cases, it will be better.

Students will learn at their own pace. Some students will jump ahead, while some will lag behind, in much the same was in a normal school.

We also need to consider the teacher's needs and responsibilities. Teachers will not have physical responsibility for student safety. Social interaction and disruptive behavior will be lessened. Along with the technical challenges of video conferencing, new techniques will be learned. The new 'normalcy' will also prepare students for the new workplace of remote work.

As many predicted Covid 19 has transformed our lives, at work, at home, and in education.

Distance learning may not be appropriate for early elementary school where physical presence is important for developmental socialization.

Surveys of parents with school-age children reveal the mental health challenges faced by their young ones. A Gallup poll conducted in May found that among parents with children in kindergarten through grade 12, 29% said their child was “already experiencing harm” to their emotional or mental health because of physical distancing and pandemic-related closures of schools and businesses.

Classroom with Social Distancing

Typical Classroom, without social distancing

“Trauma on Top of Trauma”

Students from kindergarten through graduate school are already returning to their studies amid both the pandemic and widespread protests of racial injustice and police violence. Experts worry that these compounding stressors are taking a toll on the mental, emotional, and physical health of young people.

Finally, whatever happens, it is an opportunity to study the effects and make plans for a new future.

Stressors Take Toll on Students’ Mental Health - California Health Care Foundation

The Future Of Prosthetics Depends On A.I

Back in 2011, archeologists unearthed one of the oldest known prosthetic devices; a wooden toe buried with Egyptian mummies some 3,000 years ago. While aesthetically it packs a steampunk look, this artificial toe was far from being a cosmetic item. After testing replicas, researchers found that they were indeed practical devices that helped in walking. While throughout the millennia the materials have changed, prosthetics only evolved in recent decades with the advent of robotic prostheses.

Advance forward 5-6 millennia

From steampunk Egyptian mummies to cyberpunk brain-controlled prosthetics 

So, from bits and bytes of archeological digs, we move on to bits and bytes of technology to build anthropomorphic machines to attach to ourselves as we move toward biosynthetic human beings.

The technology is already here including material sciences, electronic, microchips, sensor technology, and human innovation, curiosity and goals.

The necessary steps to develop a self-sustaining business include already well-known startup implementation, venture capital funding, and committed leaders. The future prosthetic industry will require large amounts of capital which may include private, venture capital funding as well as existing companies in this field. A critical issue will be market demands and health payer reimbursements. Payer challenges may be met by different market segments. Military and Veterans Benefits will be the first to source this capability as many amputations result from battle.  It would seem the government will invest in R&D for prosthetics just as it has for military robotics, which includes augmented skeletons for load-carrying heavy supplies, as well as robotic mules. 

Autonomous robotic mule

The future has arrived. Want proof? Check out these amazing robotic exoskeletons

The Future Of Prosthetics Depends On A.I. | LinkedIn

Common class of drugs linked to onset of Alzheimer’s – Scientific Inquirer

As we age more and more people develop Alzheimer's disease.  This form of dementia is a specific one with 'tangles' and tau proteins infiltrating parts of the brain.  It is only one form of dementia.

Given the growing number of aged people and increasing life span, Alzheimer's Disorder has become a public health problem. People with Alzheimer's disease do not usually die from it and are victim to other disorders of aging, heart disease, hypertension, cancer, or kidney disease.  Sadly it robs them, family and friends of a loved one.

Researchers have searched for a "cause" suspecting toxins, drugs, environmental and immune disorders.  Alzheimer's disorder seems to have become more prevalent in a time when patients are subject to the use of many more drugs.  Could this be a factor in Alzheimer's Disorder?

A team of scientists, led by researchers at the University of California San Diego School of Medicine, report that a class of drugs used for a broad array of conditions, from allergies and colds to hypertension and urinary incontinence, may be associated with an increased risk of cognitive decline, particularly in older adults at greater risk for Alzheimer’s disease (AD)

The study done at the University of California San Diego is published in Neurology found that patients taking anticholernigic drugs (AD) and who had genetic markers for AD were four times more likely to develop MCI (mild cognitive impairment) a term which is inclusive of AD)

Anticholinergics can treat a variety of conditions, including:

Urinary incontinence, overactive bladder (OAB), chronic obstructive pulmonary disorder (COPD), certain types of poisoning

They also help block involuntary muscle movements associated with certain diseases such as Parkinson’s disease. Sometimes, they’re used before surgery to help maintain body functions while a person is treated with anesthesia.

List of anticholinergics

Anticholinergics are only available with a doctor’s prescription. Examples of these drugs include:

atropine (Atropine)
belladonna alkaloids
benztropine mesylate (Cogentin)
aclidinium
cyclopentolate (Cyclogyl)
darifenacin (Enablex)
dicyclomine
fesoterodine (Toviaz)
flavoxate (Urispas)
glycopyrrolate
homatropine hydrobromide
hyoscyamine (Levsinex)
ipratropium (Atrovent)
orphenadrine
oxybutynin (Ditropan XL)
propantheline (Pro-banthine)
scopolamine
methscopolamine
solifenacin (VESIcare)
tiotropium (Spiriva)
tolterodine (Detrol)
trihexyphenidyl
trospium

All of these drugs are very commonly used in elderly patients.

To add to this list we must also include certain other drug classes that are used for other purposes and have anticholernigic properties, such as Benadryl  (diphenhydramine (commonly used for allergy.

Many of these drugs are used and coexist with patients with Alzheimer's disorder. Add to this as we age are metabolic changes. Dosage may be a factor for elderly patients.  Doses should be adjusted appropriately.



There is conflicting information regarding the role of tau proteins, neurofibrillary tangle in AD. Are they cause, or effect?

Some information examines the role of gum disease, specifically the presence of the bacterium, p.gingivales.

There are many confounding factors for investigators to tease out in their search for a cause.





















Common class of drugs linked to onset of Alzheimer’s – Scientific Inquirer

COVID-19 Vaccine Research Is Facing a Monkey Shortage - The Atlantic

In the past seven months, more than 100 COVID-19 vaccines, therapies, and drugs have been pushed into development. But for any of these treatments to make it to humans, they usually have to face another animal first: a monkey. And here, scientists in the United States say they are facing a bottleneck. There just aren’t enough monkeys to go around.

“Nationally, there is basically a big shortage,” says Koen Van Rompay, an infectious-disease scientist at the California National Primate Research Center. Primate research in the U.S. is expensive and often controversial, making it challenging even in normal circumstances. The pandemic has made acquiring monkeys even harder. “We can’t find any rhesus any longer. They’ve completely disappeared,” says Mark Lewis, the CEO of Bioqual, a contract research organization that specializes in animal testing. Scientists in academia and industry alike are all competing for a limited pool of monkeys.

The reasons for the shortage are threefold. First, COVID-19 has created extraordinary demand for monkeys. Second, this coincided with a massive drop in supply from China, which provided 60 percent of the nearly 35,000 monkeys imported to the U.S. last year and which shut off exports after COVID-19 hit. And third, these pandemic-related events are exacerbating preexisting monkey shortfalls. A 2018 National Institutes of Health report had found that NIH-funded national primate centers would be unable to meet future demand and specifically discussed a “strategic monkey reserve” to provide “surge capability for unpredictable disease outbreaks.” A disease outbreak is upon us; the strategic monkey reserve was never created. Furthermore, monkeys infected with COVID-19 have to be kept in Animal Biosafety Level 3 labs, which have specific design and ventilation requirements to prevent the spread of pathogens. The U.S. has a limited number of ABSL-3 labs.

The result, Van Rompay says, is that he gets emails and calls weekly from companies looking to test COVID-19 treatments at the California research center, one of the seven NIH-funded primate centers that work with both academic and industry researchers. “I have to tell them, ‘I’m sorry, we are not allowed to start your research,’” he says. With so much demand for monkeys, the NIH is now centrally deciding which studies can use the national primate centers under a public-private initiative called Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV), creating a new bureaucratic bottleneck. Meanwhile, non-COVID-19 research is also getting pushed aside.

Monkeys account for just 0.5 percent of the animals used in U.S. biomedical research, but they typically represent the last step before human clinical trials. They are closely related to humans, after all—so closely related that scientists refer to the research animals as, technically, “nonhuman primates.” For example, monkey and human immune systems are so similar that vaccine studies can use the same tests to measure antibodies in both. “Literally the same test,” says Skip Bohm, the associate director of the Tulane National Primate Research Center. The similarity means that monkeys are also a good model for testing the agents that help boost the effectiveness of a vaccine, says JoAnne Flynn, a vaccine researcher at the University of Pittsburgh.

The rush to manufacture Covid 19 vaccines has caused biopharmaceutical companies to bypass simian testing with new vaccines. This was always an additional step in clinical trials for adjusting dosages and for safety in children, as juvenile monkeys were also tested.  The FDA protocols have been in existence for several decades.  Bypassing simian trials may be faster, but will it be as safe?
As COVID-19 vaccine development has moved forward at an unprecedented pace, though, some pharmaceutical companies have started human trials before monkey studies have concluded. And with monkeys so hard to come by, others are wondering if certain studies can be skipped altogether. Linda Marbán, the CEO of the biotech company Capricor Therapeutics, says her company originally tried to test its vaccine candidates at the California primate center. It couldn’t get in. She’s now exploring how to go straight into human-safety trials.

Scientists who work with primates, however, say that the animal research still offers certain advantages. Monkeys can be challenged—that is, deliberately infected with COVID-19 after being given an experimental vaccine. Researchers can then follow the animals’ exact progression of disease or lack thereof, tracking how quickly antibody levels shoot up or whether a vaccine reduces how long the monkey sheds the virus. These details are harder to get in human trials because people are naturally exposed to COVID-19 and aren’t being monitored every day. (Although some researchers have proposed human challenge trials for COVID-19, the idea is controversial and none has begun.)
Simians are used because they are also considered primates, the same family that human beings are a member.  The close genetic relationship sometimes allow researcher to test medications prior to actual human trials.

The relative scarcity of these monkeys is also due to activism several decades ago. PETA and other animal rights groups invaded and destroyed hundreds of monkeys by breaking into laboratories and destroying them.  This provoked national attention to the plight of research animals.  Many ongoing research studies were destroyed, cancelled or terminated outright. No one can argue with humane treatment of animals during test studies. 

PETA today remains quite active with celebrities advocating kindness to animals. These activities draw quite a bit of interest.  Many of their claims are half-truths and accusations of NIH being cruel to animals is untrue, bordering on libel.

Following the PETA protests in the 1980s Congress, the FDA and NIH reviewed their practices. and established new regulations.

The animals were bred in companies specifically tasked with breeding monkeys, mice (some) are genetically modified for specific diseases. Knock-out mice have been in use for several decades and are instrumental in treating, studying and modeling different kinds of cancer, obesity, heart disease, diabetes, arthritis, substance abuse, anxiety, aging and Parkinson disease.

Regulation and inspection by Animal Abuse Abundant in Spite of AAALAC Accreditation - USDA Data reveals repeated citations of animal laboratories.

Both sides have self-interest involved. Research laboratories and








-19 Vaccine Research Is Facing a Monkey Shortage - The Atlantic

Introducing Rare Diseases- Optime Care- Find your Medications

Are you in a family with a rare disorder? Finding sources for information about rare genetic diseases can be challenging.  Even physicians may not have much experience diagnosing or treating some disorders.

Another term is "small patient communities".  There are internet sources that help you and your caregiver community in treating you.

A rare disease is generally considered to be a disease that affects fewer than 200,000 people in the United States at any given time. There are more than 6,800 rare diseases. Altogether, rare diseases affect an estimated 25 million to 30 million Americans.

NORD is a central source of information for patients and providers. 

The topmost common small patient communities:

Mad cow disease, SARS (no longer a rare disease.) Some diseases grab the headlines. ...

• Morgellons. ...
• Progeria. ...
• Water allergy,"aquagenic urticaria" ...Yes, there is such a thing...only 30 cases have been reported
• Foreign accent syndrome. ...
• Laughing Death. ...
• Fibrodysplasia ossificans progressiva (FOP) ...
• Alice in Wonderland syndrome.  Strange things happen when you have an episode of AIWS
• Your body parts or things around you may look bigger, smaller, closer, or farther away than they really are.
• Straight lines may look wavy.
• Things that are still may seem to move.
• Three-dimensional objects may look flat.
• Things may change colors or tilt to the side.
• Faces may look distorted.
• Colors may look extra bright.
• People and objects may look stretched out.
• Doctors aren't sure why some people have these unusual changes in perception. But it often starts when children are very young.
• 
  
• AIWS involves changes to parts of your brain that deal with sensory information -- what you see and hear. These changes affect how you see your own body and its relation to the world around you.
• 
  
• Doctors believe AIWS might be a type of migraine aura. Auras are visual and other sensory problems some people get before or during a headache. They can cause things like flashing lights, shimmering spots, ringing in your ears, or a tingling in your hands.
• 
  
• AIWS often happens before, during, or after a migraine. But it also can happen with these other conditions:
• 
  
• 
  

Introducing Rare Voices - Optime Care

Lawmakers cleared the way for telemedicine, but seniors need access, training

Technology and lack of broadband are holding back some seniors. 

Monica Stynchula, a member of the Florida Telehealth Advisory Council and founder of ReunionCare, a digital platform for managing seniors’ care, said the biggest barrier to telemedicine is lack of universal broadband access.

The Trump administration has loosened restrictions on insurance coverage for telemedicine so doctors’ offices are able to bill for virtual appointments just as they do for office appointments. But some patient advocates worry that barriers still remain for seniors, one of the populations most vulnerable to COVID-19.

Telemedicine helps avoid possibly risky in-person visits, but access to the technology (including smartphones, Wi-Fi, and broadband), the ability to operate the technology, and cognitive or age-related impairment may affect the ability to take advantage of virtual visits.

While 96 percent of American adults use smartphones, almost half of Americans over the age of 65 still don’t have one, and nearly half lack broadband access, according to a Pew Research study conducted last year.

While there are seniors who function fully and are very interested in new technology and pride themselves on keeping up with millennials there are portions of the demographic with cognitive decline and/or physical limitations in assisted living or skilled nursing facilities. This population requires caregivers who also require training in telehealth and remote monitoring.

The entire health ecosystem needs the training to practice 21st Century medicine

“We’re seeing insurers clearing a lot of the barriers out of the way for this, but that last part, making sure that users are able to use the services, that may be the most time-consuming part of this,” said AARP Florida spokesman David Bruns.

Researchers share concerns about the ease of use of some apps.

“Now would be a time to think about how to create technologies that are universally accessible, regardless of age, regardless of socioeconomic status, racial or ethnic background, and also (to think) about those seniors or individuals where English is not their primary language,” said Uchechi Mitchell, an assistant professor at the University of Illinois at Chicago who focuses on racial and ethnic health disparities and aging.

In Florida, where almost 500,000 seniors had limited English proficiency as of 2018, this is even more of a concern.

Mercedes Carnethon, vice chair of the department of preventive medicine at Northwestern University’s medical school, said that without improvements to apps’ interfaces or access to devices such as iPads that enable video visits, patients may resort to phone appointments, but that means doctors lose the ability to check seniors’ energy levels, skin and eye brightness and mobility, for example.
“When we talk about frailty and looking at muscle function, you know, how many chair stands can you do? Well, suddenly, if you have an iPad, you could set that iPad down and you could watch on video, this older adult stand up and sit down unaided, repeatedly, and you could do some of these functional tests and witness them in real time,” she said. “You can’t do that on the phone.”

Carnethon added that telehealth may help to eliminate race-based disparities in health outcomes for seniors, such as diabetes, high blood pressure and COVID-19, by making it easier for doctors to monitor patients’ symptoms from home.

In practice, however, Florida-based doctors and patients have faced roadblocks in implementing the technology. Dr. Mark Moseley, chief clinical officer at USF Health in Tampa, said that while USF was able to set up a telehealth infrastructure within a week in March, it has conducted only about 60,000 telehealth appointments, out of the approximately 85,000 scheduled since then.

“What we learned pretty early on is that we had to call before their appointment,” he said. He said that staff would learn on these calls that some seniors lacked reliable internet access, devices or technical knowledge to set up a video appointment, so follow-up visits would be converted to phone calls.

The process requires an intermediary, someone on site who sets up the calls.
There are intermediaries that also fulfill this function, independently or part of a portal, health information exchange, such as Reunion Care. 

Lawmakers cleared the way for telemedicine, but seniors need access, training

First Person to Be Reinfected with COVID-19 Recorded in Hong Kong

Can I get Coronavirus more than once? That is a common question.  Yes.  This story from Hong Kong elaborates on your question.   

In many ways Coronavirus acts like most viruses. It's the mechanism of action however is quite different from an ordinary "respiratory virus'. It is not a true respiratory virus although it has been channeled into the 'influenza' family.

Like other viruses, it takes the immune system about 4 weeks to produce measurable antibodies, protective or not. During this incubation period, the immune system is triggered and specific T cells (specialized lymphocytes) are released from lymph nodes, spleen, and bone marrow.  T cells have a memory from previous foreign antibodies and the new agent is sensed. The immune factory begins to 'pump out" the correct T cells to attack foreign antibodies. In HIV the virus attacked the CD4 T-cells destroying it's the capability to multiply and produce anti-HIV antibodies.

It does not appear that Coronavirus attacks T-cells.

First proven case of reinfection

The World Health Organization (WHO) stated that there's no immediate need to jump to any conclusions on the basis of one patient, per the BBC's report.

Hong Kong scientists observing the patient in question have noted that the two strains of the virus are different.

The report on the matter, written by Hong Kong University scientists and shared on Twitter, explained how the man in his thirties spent 14 days in hospital when he was first diagnosed with COVID-19 where he recovered. Following this, during a screening at the airport, he tested positive once again for the virus, despite being asymptomatic. 

 













First Person to Be Reinfected with COVID-19 Recorded in Hong Kong

Stroking Out While Black—The Complex Role of Racism | Cerebrovascular Disease | JAMA Neurology | JAMA Network

America is in the midst of a racist revolution, specifically systemic racism built into the American way of life.

Physicians have been aware of this fact for over one hundred years.  People of color have been aware of and subject to the laws of systemic racism for centuries.

Just this week the JAMA Neurology published an academic article about "Stroking Out While Black-The Complex Role of Racism."

The killing of George Floyd, an unarmed 46-year-old Black man by a White police officer in Minneapolis, led to widespread protests against police brutality. Beginning with a focus on law enforcement reforms, the protests grew in diversity and objective, evolving into a broader call to end institutionalized racism. For the first time in history, a diverse, global coalition came together to protest injustice in the societal treatment of Black lives. Perhaps it was the collision of George Floyd’s horrific death with the disproportionate and egregiously high death rates and coronavirus disease 2019 infection rates within communities of color in the US that fueled this movement. Of note, precursors of change, such as the diversity, inclusion, and equity initiatives being spawned in all major sectors (economic, education, health), hold out hope for meaningful progress. This Viewpoint highlights the complex role of racism in stroke and suggests a framework for understanding its effects.

The same may be said for the systemic disparity in health care for people of color, African American, Latino, and Native Americans.  Each group has its own issues regarding health and wellness.

Native Americans in particular are isolated often in remote areas with a paucity of health institutions, although served by the Indian Health Service.  The incidence of infectious disease, chronic illness, especially diabetes, obesity, and hypertension is much higher than in white populations.

Levels of Racism Theoretical Framework

The Levels of Racism framework delineates 3 interacting levels of racism to guide the development of interventions aimed at reducing racial differences in health outcomes.1 These include institutionalized or structural racism, personally mediated racism, and internalized racism.1 Institutionalized racism occurs when access to goods, services, and opportunities is influenced by race.1 It is also referred to as structural racism owing to its codification in organizational practice and policy, to the extent that it becomes the normative behavior—a cultural disease—without the presence of a specific transgressor. Personally mediated racism is prejudice arising from conditioned assumptions about a person’s intentions and abilities, based on race, causing implicit and explicit bias.1 Internalized racism is a by-product of structural racism and personally mediated racism, reflecting the total capitulation of the individual’s self-worth and self-esteem. It occurs when people accept racist beliefs about their own abilities and human value.1

Social Determinants of Health

Social determinants of health are the conditions in which we are born, live, learn, work, and play and their impact on our health. Differences in social determinants are linked to wealth status and drive the powerful association between a person’s zip code and life expectancy. But these conditions, operating across the socioecological spectrum of human life, are not only influenced by socioeconomic status but also by levels of racism. They include upstream factors related to health outcomes, such as housing conditions, school quality, environmental conditions, employment opportunities, access to healthy foods, and access to quality health care, all of which may be influenced by racial inequities and moderate the downstream biological processes responsible for health outcomes.

Stroke Disparities

A 2003 Institute of Medicine report,2 entitled “Unequal Treatment: Confronting Racial and Ethnic Disparities in Health Care,” provided a compelling body of research highlighting health care injustices associated with greater mortality among Black patients. These included lower quality of health services and a lower likelihood to receive appropriate medical procedures among Black vs White US citizens.2 Poorer stroke outcomes for Black Americans compared with their White counterparts have persisted for more than 50 years. For example, Black individuals are twice as likely to die of stroke than White individuals, and this disparity is not entirely explained by differences in the prevalence of traditional risk factors (as defined by the Framingham Stroke Risk Function). Indeed, data from Reasons for Geographic and Racial Differences in Stroke (REGARDS) showed that only 40% of the Black-White incidence disparity is attributable to differences in the prevalence of traditional stroke risk factors and that the source of the outstanding 60% remains unclear.3 The REGARDS investigators suggest that this excess disparity may be driven by differences in risk factor control, the differential impact of risk factors by race and nontraditional risk factors, such as for physical inactivity, diet, and psychosocial factors, including depression and discrimination.3 Others have gone a step further by tracing stroke disparities to historical slavery, racism, and segregation.4 This active legacy of slavery manifests itself in the structural inequities of American society. They cause chronic repetitive, socially structured stressors shown to elicit physiological responses associated with cardiovascular disease and premature death. Indeed, a growing body of research regarding these physical consequences of social inequality referred to as the “weathering hypothesis,” shows that its physiological responses can be measured using markers of allostatic load.

Structural Racism and Stroke

Social determinants of health are riddled with race-based inequity due to the role of racial discrimination in resource allocation that have lingered since the US government’s redlining policies. These inequities are not only remnants of slavery and de jure segregation, but also related to the widespread de facto segregation in the US today. Evidence from US Census data suggests that, while the US has become more diverse, segregation has not appreciably improved since the era of Jim Crow. The separate social worlds between Black and White individuals are driven in part by income, preference, the absence of integrated experiences to help break the cycle of preference, and discriminatory practices, such as racial steering in which real estate brokers “steer” prospective homebuyers toward or away from certain neighborhoods based on their race. Consequently, Black individuals are concentrated in neighborhoods excluded from mainstream resources. It is why the variability of school quality across neighborhoods correlates with their racial composition. Such area deprivation, captured by economic, educational, and other environmental inequalities, is associated with worse mortality. Although beyond the purview of neurologists, these conditions may be drivers of stroke risk factors, such as smoking, obesity, hypertension, and type 2 diabetes.

Personally Mediated Racism and Stroke

This form of racism influences the decision-making of policymakers and members of governing bodies responsible for resource development and allocation, contributing to structural racism and its indirect effects on health. But personally mediated racism is also directly toxic to the health of those who experience it. It can be captured and quantified by validated scales, such as the Everyday Discrimination Scale,6 a measure of subjective experiences of discrimination. Examples of daily race-based indignities are itemized on this measure and range from microaggressions (eg, being treated as if you may be dishonest or as if people may be afraid of you, or receiving poorer service than others) to profiling and police brutality. While many of the experiences described in the measure appear minor, their sheer volume and chronicity have harmful consequences, including hypertension, higher levels of inflammation, and premature mortality.6 Moreover, even the recall of these experiences, a feature of rumination, produces adverse blood pressure responses comparable with those that occurred when the person was exposed.7

Internalized Racism and Stroke

Internalized racism and the resulting self-devaluation, self-rejection, engagement in risky health practices, and hopelessness1 has been linked to nontraditional stroke risk factors. These include depression, anxiety disorders, and several maladaptive behaviors in addition to cardiovascular disease.

The hydra-headed disadvantage of being deprived and a Black individual supports the need to include racism as a distinct construct of health disparities. Beyond social determinants of health, the insidious and paroxysmal health effects of racism directed at Black people, and which begins early in life, maybe underestimated, potentially explaining some of the excess Black-White stroke disparities observed. We call for increased funding and research that expands the use of an “equity lens” in the design and evaluation of stroke interventions and the role of racism in stroke outcomes. Promising areas of study include an examination of racism’s vascular effects on stroke risk and on differences in blood pressure control.

Stroking Out While Black—The Complex Role of Racism | Cerebrovascular Disease | JAMA Neurology | JAMA Network

Employers expect to boost virtual care offerings, survey finds | Healthcare Dive

Large employers expect to pay more than $15,500 per employee for health coverage next year, 5.3% higher than the $14,769 expected this year, according to an annual survey from nonprofit Business Group on Health. That's slightly up from the 5% increase employers estimated in each of the previous five years. 

Employers are increasingly welcoming virtual care options. About 80% of respondents said they believe telehealth will play a significant role in how care is delivered in the future, compared with 64% in 2019 and 52% in 2018. More than half said they will offer more virtual care to employees next year.

Employers also plan to expand access to virtual mental health and emotional well-being services. More than 90% said they will offer telemental health services, and 54% plan to lower or waive those costs in 2021.

Insight:

Six months into the pandemic, insurance companies are reporting record profits as Americans continue delaying routine in-person care. Many have turned to telehealth services or stopped receiving preventive and elective care altogether, making the exact cost employers will pay for workers' health coverage "a moving target" over the next few years, Ellen Kelsay, president, and CEO of the group said.

While the increased costs of treating pandemic patients, the. the pandemic caused patients to defer routine care, or even see their physician for possibly serious conditions, such as chest pain. After the acute wave of. coronavirus emergency visits, emergency rooms became empty. Patients are still wary of hospitals and doctors' offices.

Patient-provider encounter trends have stabilized, but remain significantly lower than before COVID-19

In-person doctor visits plummeted during the start of the COVID-19 crisis in the United States, but have rebounded to a rate somewhat below pre-pandemic levels, according to a new analysis issued by The Commonwealth Fund and conducted by researchers from Harvard Medical School, Harvard University and the life sciences firm Phreesia.

According to data compiled through Aug. 1, all physician visits were down 9% from pre-pandemic levels. That's significantly improved compared to data from late March when visits were down 58%. Although the rebound got major traction beginning in late April, it began plateauing in early June, when all visits were 13% lower than normal. As of early August, in-person visits were down 16% compared to pre-COVID levels. States that are currently coronavirus hot spots are seeing bigger declines than states where the case levels are lower.

Meanwhile, telemedicine encounters have settled in at rates much higher than pre-pandemic levels. However, they still make up just a fraction of patient-provider encounters for care. As of the start of this month, they comprised 7.8% of all such encounters. That's compared to a peak of 13.8% in the latter part of April. Prior to COVID-19, they were only 0.1% of all visits.

On another note:

The use of telehealth services has skyrocketed since the Trump administration broke down regulatory barriers to access early into the pandemic.

In the week ended March 7, only 11,000 elderly and disabled Americans in Medicare used telehealth. By the week ended April 25, that had snowballed to 1.7 million Medicare beneficiaries.

But providers who invested heavily in those services and the companies that furnish them are dependent on those regulations to make or break future use.

AHA said it was pleased with President Donald Trump's Aug. 3 executive order to improve telehealth access in rural communities through a new payment model for rural hospitals and accountable care organizations that will use upfront and capitated payments.

And while CMS' 2021 physician fee schedule draft also released earlier this month offers additional telehealth flexibilities, it's still not enough to ensure continued virtual care access, according to the hospital lobby.

CMS' proposal notably excluded payment for audio-only telehealth visits, which AHA strongly recommends it provide.

AHA also recommends allowing annual beneficiary consent to virtual treatment to be obtained at the same time, not necessarily before, services are provided. Hospitals should retain the ability to capture diagnoses impacting risk adjustment scores through telehealth visits too, according to AHA.

The 2021 PFS proposal does include the permanent addition of nine new telehealth codes, and 13 will be covered through the calendar year in which the public health emergency ends, to give physicians a chance to deliver services virtually before CMS decides whether to permanently allow them.

Other proposed changes from CMS include allowing Medicare providers to conduct evaluation and management home visits for established patients virtually, allow an emergency room E/M virtual visit for minor to moderately severe health issues and expand some telehealth services similar to those already covered by Medicare, like for group psychotherapy or care for patients with cognitive impairment.

The administration has viewed telehealth favorably, launching a pledge to "Embrace Technology to Advance America’s Health" on Wednesday in an effort to "reassure patients, providers, and payers that telehealth is here to stay and will be covered over the long term."

The pledge calls on commercial insurers to commit to expanding flexible and affordable telehealth options, and on providers to accelerate the adoption of telehealth services, though it's still unclear exactly how far CMS will go to help facilitate those expansions long-term.

Employers expect to boost virtual care offerings, survey finds | Healthcare Dive

US FDA announces emergency authorization for convalescent plasma to treat Covid-19

The FDA said more than 70,000 patients had been treated convalescent plasma, made using the blood of people who have recovered from coronavirus infections.  

On Sunday, a source who is close to the White House Coronavirus Task Force told CNN the FDA had reviewed additional data to inform its impending EUA decision. This official has not personally reviewed the data. They added the FDA is under no obligation to consult anyone outside the agency about its decision.  (they are the buck stops here agency for pharmaceuticals, and their protocols are rigid and sacrosanct) More about that later in one of my next blogs.

Researchers hope this old-fashioned treatment will work for coronavirus.  Convalescent plasma is taken from the blood of people who have recovered from Covid-19. At the end of March, the FDA set up a pathway for scientists to try convalescent plasma with patients and study its impact. It has already been used to treat more than 60,000 Covid-19 patients. However, like blood, convalescent plasma is in limited supply and must come from donors. And while there are promising signals from some studies, there is not yet randomized clinical trial data on convalescent plasma to treat Covid-19. Some of those trials are underway.

Impact of an EUA

The New York Times reported last week an FDA emergency use authorization for blood plasma to treat Covid-19 was on hold after NIH officials intervened. The hold came after a group of federal health officials -- including National Institutes of Health Director Dr. Francis Collins, National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci and Dr. H. Clifford Lane, NIAID deputy director -- stepped in to argue the emerging data on the treatment was too weak, the Times reported Wednesday, citing two senior administration sources.

n response to CNN, Dr. Anand Shah, FDA's deputy commissioner for medical and scientific affairs, said he couldn't comment but suggested the NIH was out of line.

"In general, NIH is not involved in the decision-making process at the FDA and does not have the entirety of confidential data the FDA uses to make these regulatory decisions," Shah said in a statement sent to CNN.

"We take seriously our mandate to follow the data and science on the review of medical products to prevent or treat COVID-19 based on the agency's established legal and regulatory standards," Shah added, saying the FDA appreciated the work of NIH and would collaborate with its sister agency.

A senior administration official told CNN's Jim Acosta on Sunday the expected emergency use authorization announcement is an important development.

Comment:  It is surprising. that FDA would make a decision without statistics from the CDC and Anthony Fauci M.D. who heads up the  Coronavirus task force. The reporting is most likely inaccurate.

Attacks on Public Health Officials During COVID-19 |

The unimaginable seems to be spreading almost as fast at Covid-19.  Public health officials have reported death threats to themselves and/or their families

(On June 24, 2020, California Governor Gavin Newsom remarked on a disturbing phenomenon: health officers are “getting attacked, getting death threats, they’re being demeaned and demoralized.”1 At least 27 health officers in 13 states (including Nichole Quick of Orange County in southern California, Ohio Health Director Amy Acton, and West Virginia Health Officer Cathy Slemp) have resigned or been fired since the start of the coronavirus disease 2019 (COVID-19) pandemic. Across the US, health officers have been subject to doxing (publishing private information to facilitate harassment), angry and armed protesters at their personal residences, vandalism, and harassing telephone calls and social media posts, some threatening bodily harm and necessitating private security details.1) 

The present harassment of health officials for proposing or taking steps to protect communities from COVID-19 is extraordinary in its scope and nature, use of social media, and danger to the ongoing pandemic response. It reflects a misunderstanding of the pandemic, biases in human risk perception, and a general decline in public civility. Some of these cases resist easy fixes, but elected officials and health officials can take certain actions to help address the problem.

Today’s increasingly routine harassment and threats against health officials have much in common with growing resistance to childhood vaccination. Since the 2015 measles outbreak that focused attention on vaccine policy, individuals opposed to vaccination mandates have attacked health officials and legislators online or in-person in Oregon, Washington, New York, New Jersey, and Colorado. For example, in 2019, protesters threw blood onto California legislators from the Senate gallery; State Senator Richard Pan received death threats and was physically assaulted. Some of the same groups, joined by other individuals frustrated with public health officials, are now actively resisting efforts to require masks, reinstitute business closures, and prepare for COVID-19 vaccination, jeopardizing the eventual acceptance of vaccines.2

What explains the unprecedented hostility to public health officials during COVID-19? Although acceptance of public health orders for COVID-19 is often framed as a “red vs blue” issue, even libertarians accept that liberty may be curtailed when its exercise harms others. However, people’s ability to perceive such harm can be undermined by decisional biases known to affect human thinking.3 Omission bias creates a preference for risks associated with doing nothing (ie, letting the virus spread) over those linked to affirmative acts, such as public health orders. Distance bias and optimism bias may be operating for those who believe COVID-19 will not seriously affect them or their loved ones. In an information space flooded with conflicting information, confirmation bias allows some people to dismiss evidence that does not comport with their preexisting beliefs.

Today I attended a meeting online with Sanjay Gupta MD (CNN correspondent) and Anthony Fauci M.D. a member of the Task Force Coordinators for the White House.  He mentioned that he hired security consultants to assure the safety of his family.  Fauci has been working 20 hour days for several months. He does not seem unusually stressed by events looking youthful and bright-eyed despite his birthdays.  He is three years older than I am and looks ten years younger. Sanjay Gupta asked how he does it.  Fauci replied it was due to the extensive every other night and weekend routines of internship and residency back in the day before regulations were put in place to prevent such "abuse" claimed by today's trainees.  Fauci seemed non-plussed about current events, perplexed about today's attitudes about government and scientists. Sanjay Gupta seemed worried and asked if he (Fauci) had a succession plan for his eventual exit from NIH, he went on to say as long as he was at the top of his game, there were no plans to exit the NIH, adding his wife would guide him when to pack it in.  

Fauci has no danger of being fired having been selected and appointed by a committee of peers at NIH and national scientific experts. Trump no longer asks Fauci nor Dr. Birx to appear with him to bolster his weak positions.

Despite the pandemic I know we would be much worse off had Fauci not been present. It is all relative, we have to work with what we have, and have no wishful thinking, we should have done this or that.   The present situation is like the perfect storm a collision of events that we must ride out to survive.  The present political division adds fuel to the storm.  The captain of the ship is indisposed, and the executive officers must take over.  We do have very competent experts in many departments, and loyalties to the captain aside intelligent people must ignore bad commands.  That is a major problem as well as conflicting orders from governors, mayors, and other local representatives. 

Fauci's plans include the rapid timely delivery of test logistics and vaccines. Although he indicated he hopes he will not be around for the next pandemic he assured us all that there would be another pandemic as sure as this one was predicted.  He emphasized the importance of lessons learned and investing in technology, and logistics to be ready for the next one.





Attacks on Public Health Officials During COVID-19 | Infectious Diseases | JAMA | JAMA Network